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PE Global is currently recruiting for a QA Manufacturing Compliance Specialist on behalf of a leading pharmaceutical company based in Sligo. This is an initial 12-month contract role.
Responsibilities
* Ensure that all products leaving meet the standards required for marketed and investigational drug products.
* Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
* Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
* Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
* Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
* Review/Audit of completed Batch Records.
* Review of Manufacturing Logs as required.
* Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
* Completion of Line Clearance activities.
* Completion of Incoming Raw Material checks, including product status maintenance (as required).
* Provide Stability Program Support, sample pulls, weekly checks, protocol generation (as required).
* Finished product status maintenance, including labelling as required.
* Administration of Quality Logs, QA Hold, Sample Request.
* Lead operations floor daily walk around of manufacturing areas.
* Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
* Other support as deemed necessary.
Education and Experience:
* Third level degree in a science, quality or engineering discipline.
* Ideally previous experience in a quality role
* A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
* Experience in aseptic processing gained within either a quality or operations role is highly desirable.
* A strong knowledge of regulatory requirements is required.
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